Evaluating the efficacy and safety of the currently available once-every-two months long-acting injectable formulations of aripiprazole for the treatment of schizophrenia or as a maintenance monotherapy for bipolar I disorder in adults

References

• Saha S, Chant D, Welham J, et al. A systematic review of the prevalence of schizophrenia. PLoS Med. 2005;2(5):e141. doi: 10.1371/journal.pmed.0020141
   PubMed Web of Science ®Google Scholar
• Merikangas KR, Jin R, He J-P, et al. Prevalence and correlates of bipolar spectrum disorder in the world mental health survey initiative. Arch Gen Psychiatry. 2011;68(3):241–251. doi: 10.1001/archgenpsychiatry.2011.12
   PubMed Web of Science ®Google Scholar
• Millier A, Schmidt U, Angermeyer MC, et al. Humanistic burden in schizophrenia: a literature review. J Psychiatr Res. 2014;54:85–93. doi: 10.1016/j.jpsychires.2014.03.021
   PubMed Web of Science ®Google Scholar
• Samalin L, Murru A, Vieta E. Management of inter-episodic periods in patients with bipolar disorder. Expert Rev Neurother. 2016;16(6):659–670. doi: 10.1080/14737175.2016.1176530
   PubMed Web of Science ®Google Scholar
• Semahegn A, Torpey K, Manu A, et al. Psychotropic medication non-adherence and its associated factors among patients with major psychiatric disorders: a systematic review and meta-analysis. Syst Rev. 2020;9(1):17. doi: 10.1186/s13643-020-1274-3
   PubMed Web of Science ®Google Scholar
• Samalin L, Belzeaux R. Why does non-adherence to treatment remain a leading cause of relapse in patients with bipolar disorder? Eur Neuropsychopharmacol. 2023;73:16–18. doi: 10.1016/j.euroneuro.2023.04.012
   PubMed Web of Science ®Google Scholar
• Sendt K-V, Tracy DK, Bhattacharyya S. A systematic review of factors influencing adherence to antipsychotic medication in schizophrenia-spectrum disorders. Psychiatry Res. 2015;225(1–2):14–30. doi: 10.1016/j.psychres.2014.11.002
   PubMed Web of Science ®Google Scholar
• Jawad I, Watson S, Haddad PM, et al. Medication nonadherence in bipolar disorder: a narrative review. Ther Adv Psychopharmacol. 2018;8(12):349–363. doi: 10.1177/2045125318804364
   PubMed Web of Science ®Google Scholar
• Sajatovic M, Valenstein M, Blow FC, et al. Treatment adherence with antipsychotic medications in bipolar disorder. Bipolar Disord. 2006;8(3):232–241. doi: 10.1111/j.1399-5618.2006.00314.x
   PubMed Web of Science ®Google Scholar
• Lähteenvuo M, Paljärvi T, Tanskanen A, et al. Real-world effectiveness of pharmacological treatments for bipolar disorder: register-based national cohort study. Br J Psychiatry. 2023;223(4):456–464. doi: 10.1192/bjp.2023.75
   PubMed Web of Science ®Google Scholar
• Lin D, Thompson-Leduc P, Ghelerter I, et al. Real-world evidence of the clinical and economic impact of long-acting injectable versus oral antipsychotics among patients with schizophrenia in the United States: a systematic review and meta-analysis. CNS Drugs. 2021;35(5):469–481. doi: 10.1007/s40263-021-00815-y
   PubMed Web of Science ®Google Scholar
• Milz R, Benson C, Knight K, et al. The effect of longer dosing intervals for long-acting injectable antipsychotics on outcomes in schizophrenia. Neuropsychiatr Dis Treat. 2023;19:531–545. doi: 10.2147/NDT.S395383
   PubMed Web of Science ®Google Scholar
• de Filippis R, De Fazio P, Gaetano R, et al. Current and emerging long-acting antipsychotics for the treatment of schizophrenia. Expert Opin Drug Saf. 2021;20(7):771–790. doi: 10.1080/14740338.2021.1910674
   PubMed Web of Science ®Google Scholar
• Correll CU, Kim E, Sliwa JK, et al. Pharmacokinetic characteristics of long-acting injectable antipsychotics for schizophrenia: an overview. CNS Drugs. 2021;35(1):39–59. doi: 10.1007/s40263-020-00779-5
   PubMed Web of Science ®Google Scholar
• Tadori Y, Forbes RA, McQuade RD, et al. Characterization of aripiprazole partial agonist activity at human dopamine D3 receptors. Eur J Pharmacol. 2008;597(1–3):27–33. doi: 10.1016/j.ejphar.2008.09.008
   PubMed Web of Science ®Google Scholar
• Parabiaghi A, Tettamanti M, D’Avanzo B, et al. Metabolic syndrome and drug discontinuation in schizophrenia: a randomized trial comparing aripiprazole olanzapine and haloperidol. Acta Psychiatr Scand. 2016;133(1):63–75. doi: 10.1111/acps.12468
   PubMed Web of Science ®Google Scholar
• Cuomo A, Beccarini Crescenzi B, Goracci A, et al. Drug safety evaluation of aripiprazole in bipolar disorder. Expert Opin Drug Saf. 2019;18(6):455–463. doi: 10.1080/14740338.2019.1617847
   PubMed Web of Science ®Google Scholar
• ARISTADA-PI.pdf [Internet]. [cited 2023 Nov 24]. Available from: https://www.aristadahcp.com/downloadables/ARISTADA-PI.pdf
   Google Scholar
• Hard ML, Mills RJ, Sadler BM, et al. Pharmacokinetic profile of a 2-month dose regimen of Aripiprazole Lauroxil: a phase I study and a population pharmacokinetic model. CNS Drugs. 2017;31(7):617–624. doi: 10.1007/s40263-017-0447-7
   PubMed Web of Science ®Google Scholar
• Abilify-M-PI_0.pdf [Internet]. [cited 2023 Nov 24]. Available from: https://www.otsuka-us.com/sites/g/files/qhldwo4671/files/media/Abilify-M-PI_0.pdf
   Google Scholar
• abilify-maintena-epar-product-information_en.pdf [Internet]. [cited 2023 Dec 1]. Available from: https://www.ema.europa.eu/en/documents/product-information/abilify-maintena-epar-product-information_en.pdf
   Google Scholar
• 217006s000lbl.pdf [Internet]. [cited 2023 Dec 1]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217006s000lbl.pdf
   Google Scholar
• Weiden PJ, Claxton A, Kunovac J, et al. Efficacy and safety of a 2-month formulation of aripiprazole lauroxil with 1-day initiation in patients hospitalized for acute schizophrenia transitioned to outpatient care: phase 3, randomized, double-blind, active-control ALPINE study. J Clin Psychiatry. 2020;81(3):19m13207. doi: 10.4088/JCP.19m13207
   PubMed Web of Science ®Google Scholar
• Nasrallah HA, Weiden PJ, Walling DP, et al. Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study. BMC Psychiatry [Internet]. 2021;21(1). doi: 10.1186/s12888-021-03420-x
   PubMed Web of Science ®Google Scholar
• Harlin M, Yildirim M, Such P, et al. A randomized, open-label, multiple-dose, parallel-arm, pivotal study to evaluate the safety, tolerability, and pharmacokinetics of aripiprazole 2-month long-acting injectable in adults with schizophrenia or bipolar I disorder. CNS Drugs. 2023;37(4):337–350. doi: 10.1007/s40263-023-00996-8
   PubMed Web of Science ®Google Scholar
• Citrome L, Such P, Yildirim M, et al. Safety and efficacy of aripiprazole 2-month ready-to-use 960 mg: secondary analysis of outcomes in adult patients with schizophrenia in a randomized, open-label, parallel-arm, pivotal study. J Clin Psychiatry. 2023;84(5):23m14873. doi: 10.4088/JCP.23m14873
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Such P, Yildirim M, et al. Safety and efficacy of aripiprazole 2-month ready-to-use 960 mg: secondary analysis of outcomes in adult patients with bipolar I disorder in a randomized, open-label, parallel-arm, pivotal study. Curr Med Res Opin. 2023;39(7):1021–1030. doi: 10.1080/03007995.2023.2219155
   PubMed Web of Science ®Google Scholar
• American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Arlington (DC): American; 2013.
   Google Scholar
• Harlin M, Chepke C, Larsen F, et al. Aripiprazole plasma concentrations delivered from two 2-month long-acting injectable formulations: an indirect comparison. Neuropsychiatr Dis Treat. 2023;19:1409–1416. doi: 10.2147/NDT.S412357
   PubMed Web of Science ®Google Scholar
• Singh B, Yocum AK, Strawbridge R, et al. Patterns of pharmacotherapy for bipolar disorder: a GBC survey. Bipolar Disord. 2023. doi: 10.1111/bdi.13366
   Google Scholar
• Hidalgo-Mazzei D, Mantingh T, Pérez de Mendiola X, et al. Clinicians’ preferences and attitudes towards the use of lithium in the maintenance treatment of bipolar disorders around the world: a survey from the ISBD lithium task force. Int J Bipolar Disord. 2023;11(1):20. doi: 10.1186/s40345-023-00301-y
   PubMed Web of Science ®Google Scholar
• Verdolini N, Hidalgo-Mazzei D, Del Matto L, et al. Long-term treatment of bipolar disorder type I: a systematic and critical review of clinical guidelines with derived practice algorithms. Bipolar Disord. 2021;23(4):324–340. doi: 10.1111/bdi.13040
   PubMed Web of Science ®Google Scholar
• 021346_s31_s35_s38_s39lbl.pdf [Internet]. [cited 2023 Nov 24]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf
   Google Scholar
• Pacchiarotti I, Tiihonen J, Kotzalidis GD, et al. Long-acting injectable antipsychotics (LAIs) for maintenance treatment of bipolar and schizoaffective disorders: a systematic review. Eur Neuropsychopharmacol. 2019;29(4):457–470. doi: 10.1016/j.euroneuro.2019.02.003
   PubMed Web of Science ®Google Scholar
• Peters L, Krogmann A, von Hardenberg L, et al. Long-acting injections in schizophrenia: a 3-year update on randomized controlled trials published January 2016–March 2019. Curr Psychiatry Rep. 2019;21(12):124. doi: 10.1007/s11920-019-1114-0
   PubMed Web of Science ®Google Scholar
• Haddad PM, Correll CU. Long-acting antipsychotics in the treatment of schizophrenia: opportunities and challenges. Expert Opin Pharmacother. 2023;24(4):473–493.
   PubMed Web of Science ®Google Scholar
• Greene M, Paladini L, Lemmer T, et al. Systematic literature review on patterns of pharmacological treatment and adherence among patients with bipolar disorder type I in the USA. Neuropsychiatr Dis Treat. 2018;14:1545–1559. doi: 10.2147/NDT.S166730
   PubMed Web of Science ®Google Scholar
• Correll CU, Citrome L, Haddad PM, et al. The use of long-acting injectable antipsychotics in schizophrenia: evaluating the evidence. J Clin Psychiatry. 2016;77(Suppl 3):1–24. doi: 10.4088/JCP.15032su1
   PubMed Web of Science ®Google Scholar
• Jann MW, Penzak SR. Long-acting injectable second-generation antipsychotics: an update and comparison between agents. CNS Drugs. 2018;32(3):241–257. doi: 10.1007/s40263-018-0508-6
   PubMed Web of Science ®Google Scholar
• Mauri MC, Paletta S, Di Pace C, et al. Clinical pharmacokinetics of atypical antipsychotics: an update. Clin Pharmacokinet. 2018;57(12):1493–1528. doi: 10.1007/s40262-018-0664-3
   PubMed Web of Science ®Google Scholar
• Samalin L, Garay R, Ameg A, et al. Olanzapine pamoate for the treatment of schizophrenia–a safety evaluation. Expert Opin Drug Saf. 2016;15(3):403–411. doi: 10.1517/14740338.2016.1141893
   PubMed Web of Science ®Google Scholar
• Llorca PM, Abbar M, Courtet P, et al. Guidelines for the use and management of long-acting injectable antipsychotics in serious mental illness. BMC Psychiatry. 2013;13(1):340. doi: 10.1186/1471-244X-13-340
   PubMed Web of Science ®Google Scholar
• Correll CU, Martin A, Patel C, et al. Systematic literature review of schizophrenia clinical practice guidelines on acute and maintenance management with antipsychotics. Schizophrenia (Heidelb). 2022;8(1):5. doi: 10.1038/s41537-021-00192-x
   PubMedGoogle Scholar
• Robinson DG, Suett M, Wilhelm A, et al. Patient and healthcare professional preferences for characteristics of long-acting injectable antipsychotic agents for the treatment of schizophrenia. Adv Ther. 2023;40(5):2249–2264. doi: 10.1007/s12325-023-02455-8
   PubMed Web of Science ®Google Scholar